Quality and Regulatory Affairs
Quality and Regulatory Affairs
The SP Group offers support with Quality Systems and Regulatory Affairs for the Pharmaceutical, Dietary Supplement, and Food industries.
We provide Quality Systems Gap analysis, full documentation and procedure review, draft new and revise existing SOPs, label claim review and verification.
Additional Services:
- Establish and manage Material Review Boards and Change Control Review Boards.
- Audit readiness preparations including gap analyses.
- Investigate and write up of deviations and trends.
- Author Master Batch Records.
- Review and approve executed batch records.
- Author, review, and/or approve commissioning and qualification related documents.
- Author and/or participate in risk assessment activities in accordance with ICH Q9.
- Review and approval of commissioning documents and IQ/OQ/PQ documents.
- Author sections of regulatory filings and write supporting documents and reports.
- Author Standard Operating Procedures.
